A Study Evaluating the Safety and Efficacy of Neuroprotective Peptide CN-105 Peptide in Patients With Acute Supratentorial Intracerebral Hemorrhage

NCT06255977 | Recruiting Phase 2

• 1 other identifier: PR-CBT-2019040-2F
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Intracerebral hemorrhage (ICH) is a devastating form of cerebrovascular disease for which there are no approved therapeutics that improve outcomes. Apolipoprotein E (apoE) has emerged as a promising therapeutic target given its isoform-specific neuroprotective properties and ability to modulate neuroinflammatory responses. We developed a 5-amino acid peptide, CN-105, that mimics the polar face of the apoE helical domain involved in receptor interactions, readily crosses the blood-brain barrier, and improves outcomes in well-established preclinical ICH models. In the current study, aim to assess the safety and the efficacy of CN-105 after administration for three consecutive days in participants with acute supratentorial ICH at three different dosages.

Conditions

Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (7)

• AEs

  Number and severity of AEs throughout the duration of the study;

  90±7 days

• SAEs

  Number and severity of SAEs throughout the duration of the study;

  90±7 days

• Treatment-related mortality;

  Treatment-related mortality throughout the duration of the study;

  90±7 days

• Deaths

  Rate of mortality at 14-day, 30-day, and 90-day ;

  Day14, Day30,Day90

• Incidence of cerebritis, meningitis, ventriculitis;

  Incidence of cerebritis, meningitis, ventriculitis throughout the duration of the study;

  90±7 days

• Incidence of systemic infection associated with intracerebral hemorrhage

  Incidence of systemic infection associated with intracerebral hemorrhage throughout the duration of the study;

  90±7 days

• The incidence of hematoma extension

  The incidence of hematoma extension in 24-48 h after the first dose of study drug administration relative to baseline；

  24-48 hour （Day2~Day3）

Secondary Outcomes (8)

• Modified Rankin Scale(mRS)

  Day90

• National Institutes of Health Stroke Scale (NIHSS)

  90±7 days

• contrast head CT to evaluate progression of perihematomal edema;

  screening, 24hour (Day2), 48hour (Day3) and 120hour (Day6),Day14

• Modified Rankin Scale(mRS)

  Day30

• Glasgow Coma Scale (GCS)

  Day3, Day14

Other Outcomes (2)

• Biomarker Outcome Measures:

  screening, 48 hour(Day3), and 120 hour(Day6)

• Genetic marker

  screening

Study Arms (4)

Placebo Control: placebo

PLACEBO COMPARATOR

Intravenous infusion with placebo（same volume of saline） every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of placebo（same volume of saline） will be administered as a slow IV bolus over 30 minutes.

Drug: CN-105

Experimental: CN-105 peptide for injection 0.1 mg/kg

EXPERIMENTAL

Intravenous infusion with 0.1 mg/kg CN-105 peptide for injection every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of CN-105 will be administered as a slow IV bolus over 30 minutes.

Drug: CN-105

Experimental:CN-105 peptide for injection 0.3 mg/kg

EXPERIMENTAL

Intravenous infusion with 0.3 mg/kg CN-105 peptide for injection every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of CN-105 will be administered as a slow IV bolus over 30 minutes.

Drug: CN-105

Experimental: CN-105 peptide for injection 1.0 mg/kg

EXPERIMENTAL

Intravenous infusion with 1.0 mg/kg CN-105 peptide for injection every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of CN-105 will be administered as a slow IV bolus over 30 minutes.

Drug: CN-105

Interventions

CN-105 DRUG

Injection every 6 hours, up to a maximum of 13 doses within 72 hours.Each dose of CN-105 will be administered as a slow IV bolus over 30 minutes.

Also known as: CN-105peptide

Experimental: CN-105 peptide for injection 0.1 mg/kg; Experimental: CN-105 peptide for injection 1.0 mg/kg; Experimental:CN-105 peptide for injection 0.3 mg/kg; Placebo Control: placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is male or female, age 30 to 80 years, inclusive;
• Has a confirmed diagnosis of spontaneous supratentorial ICH by CT;
• Able to receive first dose of study drug ≤ 12 hours after onset of ICH symptoms, such as alteration in level of consciousness, severe headache, nausea, vomiting, seizure, and/or focal neurological deficits, or last-known well time;
• Has a GCS score ≥ 8 at enrollment;
• Has an NIHSS score ≥ 6
• Has Systolic BP (SBP) \< 200 mmHg
• Has given written informed consent to participate in the study in accordance with required regulations; if a participant is not capable of providing informed consent, written consent must be obtained from the participant's legally authorized representative (LAR).

You may not qualify if:

• Is pregnant or lactating;
• Has a temperature greater than 38.5℃ at Screening;
• The amount of intracerebral hemorrhage\< 5 mL（ coniglobus formula）
• ICH known to result from trauma;
• Primary intraventricular hemorrhage；
• Radiographic evidence of underlying brain tumor;
• Known unstable mass or active radiographic evidence and symptoms of herniation severely limiting the recovery potential of the patient in the opinion of the investigator;
• Known ruptured cerebral aneurysm, arteriovenous malformation, or vascular anomaly; hemorrhage from cerebral infarction, cerebral venous sinus embolization;
• Has a platelet count \< 100×109/L，(INR) \> 1.5 or irreversible coagulopathy either due to medical condition or detected before screening;
• Is taking new oral anticoagulants (such as dabigatran etexilate, rivaroxaban, apixaban, etc.) or low molecular weight heparin at the time of ICH onset;
• In the opinion of the investigator is unstable and would benefit from supportive care rather than supportive care plus CN-105;
• In the opinion of the investigator has any contraindication to the planned study assessments, including CT and MRI;
• Severe renal insufficiency: creatinine clearance \<30 mL/ min (Cockcroft-Gault formula), urea nitrogen and/or serum creatinine \>1.5×ULN;
• Is scheduled for surgical intervention throughout the trial period dose, including but not limited to hematoma evacuation (including minimally invasive and routine surgery), decompressive craniectomy, hematoma aspiration；
• Clinically significant history of cardiovascular disease, including; (1) congestive heart failure (NYHA Class \> 2); (2) unstable angina; (3) myocardial infarction in the past 12 months; (4) any need for treatment or interventional supraventricular arrhythmia or ventricular arrhythmia;

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• SDM Bio Service Inc.: collaborator

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Cerebral Hemorrhage

Interventions

apolipoprotein E mimetic peptide CN-105

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• shuya Li, Study Director

  IRB of Beijing Tiantan Hospital,Capital Medical University

  STUDY DIRECTOR

Central Study Contacts

yongjun Wang, Study Director

CONTACT

13911172565; yongjunwang111@aliyun.com

shuya Li, Study Director

CONTACT

13601367028; shuyali85@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2023
• First Posted: February 13, 2024
• Study Start: August 24, 2022
• Primary Completion: May 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Locations

CN (1)